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People also ask
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What is an FDA interact meeting?
These meetings allow innovators to gain input on novel products and development programs that present unique challenges during the early stages of product development, addressing issues prior to a pre-IND (Investigational New Drug) meeting.
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What is the difference between a Type C and a Type D meeting?
Details of the Type D meeting Unlike the Type C meeting, which may cover a broader spectrum of topics, the Type D meeting limits the discussion scope to 1 or 2 defined topics; therefore, the overall meeting timeline is more immediate than the Type C meeting.
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What is an example of a Type A FDA meeting?
Type A FDA meetings are "necessary for an otherwise stalled product development program to proceed (a critical path meeting) or to address an important safety issue." Examples of these types of meetings include: Dispute resolution meetings. Meetings to discuss clinical holds.
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What is a Type 4 meeting with the FDA?
BPD Type 4 Meeting is a pre-submission meeting to discuss the format and content of a complete application for an original biosimilar biological product application under the Program or supplement submitted under 351(k) of the PHS Act.
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What is a type of meeting with the FDA?
Type A Meetings are reserved for discussions necessary for an otherwise stalled product development program to proceed or to address an important safety issue. However, disagreement with OTP, for example, does not necessarily constitute a stalled program.
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What is an FDA regulatory meeting?
PDUFA Meetings For products subject to the Prescription Drug User Fee Act (PDUFA), formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants are a forum to discuss issues related to the development and review of FDA-regulated products.
-
What is a Type 4 meeting with the FDA?
BPD Type 4 Meeting is a pre-submission meeting to discuss the format and content of a complete application for an original biosimilar biological product application under the Program or supplement submitted under 351(k) of the PHS Act.
-
What is the difference between a type C and type D FDA meeting?
Note: Type C meetings include meetings to discuss early consultation on the use of new surrogate endpoints. 5. Type D Meeting - A meeting focused on a narrow set of issues (should be limited to no more than 2 focused topics) and should not require input from more than 3 disciplines or Divisions.
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